Status:
UNKNOWN
Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder
Lead Sponsor:
Evon Medics LLC
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Howard University
Conditions:
Opioid Use Disorder, Moderate
Opioid Use Disorder, Severe
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Opioid Use Disorders (OUD) cause significant burden to individuals, families, and the society. Our product - Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) - offers a cost-saving...
Detailed Description
Evon Medics proposes to evaluate the effectiveness of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT), as an alternative strategy for relapse prevention in patients with Opioid Us...
Eligibility Criteria
Inclusion
- Age 18- 70years
- Diagnosis of current moderate or severe OUD in the past 6 months, including the past one month
- Willing to receive study interventions and buprenorphine during the study
- Do not meet criteria for current moderate or severe use of other substance use disorders (except nicotine use disorder)
- Diagnosis of Major Depressive Disorder, Anxiety disorders, and Post-traumatic Stress disorders will be included as long as the symptoms are stable, no suicidal ideas or plans and there are no recent changes in treatment of these conditions in the last 6 weeks prior to enrollment
- No intranasal disease
- Willing to participate by signing the informed consent form and
- Have a place to stay when receiving the intervention.
Exclusion
- Any significant neurologic disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy or seizures
- Mental retardation
- Schizophrenia or bipolar disorders
- Experiencing current suicide ideas or plans
- Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, and liver cirrhosis, as determined by site PI
- History of severe traumatic nose injury that affects ability to smell, as determined by site PI
- Allergies or intolerance to aromas from plant essential oils (e.g. orange and lemon)
- Breastfeeding or Pregnancy test positive.
- On parole or probation mandated to receive treatment for OUD.
Key Trial Info
Start Date :
March 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT04850664
Start Date
March 26 2021
End Date
December 31 2022
Last Update
August 6 2021
Active Locations (4)
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1
Clinics of Dr. Edwin Chapman @ MHDG
Washington D.C., District of Columbia, United States, 20002
2
Family and Medical Counseling Service, Inc
Washington D.C., District of Columbia, United States, 20020
3
Howard University
Washington D.C., District of Columbia, United States, 20060
4
Maryland Treatment Centers @ Avery Road Treatment Center
Rockville, Maryland, United States, 20853